Methods and systems for remotely determining levels of healthcare interventions

ABSTRACT

The present subject matter relates to methods and systems utilizing wearable sensor technology to determine when a patient&#39;s health may be degrading to trigger progressively higher levels of care and involvement, from “free” hands and eyes to skilled clinicians, in order to keep patients in the lowest cost setting of care, the home, for as long as possible.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/896,306, filed May 16, 2013 the entire disclosure of which is herebyincorporated herein by reference.

TECHNICAL FIELD

The exemplary teachings herein pertain to methods and systems fordetermining levels of healthcare interventions, and in particular, tomethods and systems which monitor a patients activity and location todetermine if healthcare interventions are warranted, and what level ofhealthcare interventions are deemed necessary or required. Specifically,the present disclosure relates to methods and systems which keepspatients in the lowest cost setting of care, the home, for as long aspossible, through the use of wearable sensor technology to determinewhen a patient's health may be degrading to trigger progressively higherlevels of care and involvement, from “free” hands and eyes to skilledclinicians.

BACKGROUND

The Baby Boomer wave is yet to peak and already they are electingMedicare at the rate of 11,000 a day since June, 2012. Patients withchronic care conditions are on the rise, especially those with theso-called “life style” diseases such as Diabetes and Obesity. Thefunding model of our healthcare system cannot keep pace with the demand.As in any system, higher level of resources cost more. The highest costcare setting is the Hospital, and the lowest is care at home. Further,the staffing model of our healthcare system cannot keep pace with thedemand. The ratio between available professional caregivers and seniorswith healthcare needs is set to dramatically escalate as the baby boomerwave rolls inexorably towards its peak in 2023. The advantages of a lowcost care setting can be wiped out in an instant, if the patient healthdegrades unnoticed and they end up in the ER or an Acute care setting.

The Patient Protection and Affordable Care Act (ACA) enshrines andencourages the concept of Accountable Care Organizations (ACO).According to the ACA, an ACO “must define processes to promoteevidence-based medicine and patient engagement, report on quality andcost measures, and coordinate care, such as through the use oftele-health, remote patient monitoring, and other such enablingtechnologies.” In essence this means that healthcare providers areresponsible for the outcomes of a patient even when the patient is notin their setting of care. For instance an ACO is still accountable whena patient is discharged to an Assisted Living Facility (ALF) or to homecare to make certain the patient outcome remains positive, i.e., theACO's are responsible for the patient outcome even when they are at homeor in an ALF setting. This is ensured by the use of financial incentivesto the ACO that maintains good patient outcomes. The ACA caused a largenumber of ACO's to form quickly and they usually consist of a hospital,physicians and increasingly post acute healthcare providers such as Homecare or ALF.

The second aspect of the Affordable Care Act is the incentive to set upHealth exchanges in which Insurance companies compete to providehealthcare policies. Since pre-existing conditions and cherry picking ofthe insured are not allowed, this will cause these insurance companies,typically operating as Managed Care Organizations (MCO) to offerattractive benefits to obtain customers but will also force them to usecost containment models to make the care delivery very efficient.

The third aspect of the ACA is that state Medicaid enrolments are set toincrease dramatically. Even before ACA, states such as Texas, New Jerseyand others were experimenting with outsourcing their entire Medicaidpopulations to Managed Care entities primarily with a cost containmentby utilization management goal. Medicaid populations have a highincidence of lifestyle diseases as well and a tendency to utilize highcost healthcare such as the Emergency Room. This Medicaid expansionbrings into the main stream more patients who are homebound and/or haveone or more chronic diseases, who were previously completely outside thehealthcare system (due to lack of insurance), and whose healthcaresystem contact was primarily the ER, and who now will fall under the MCOumbrella. This additional patient load can be a very high utilizer ofcostly services.

Further, hospitals that participate in Medicare are now responsible forthe patient's outcome even after discharge; in essence, if the patientis re-hospitalized within 30 days following discharge, for the samediagnosis that they were originally in the hospital for, then thehospital has to absorb all the costs for the patient's subsequentadmission. In addition there is potential for extending this warrantyperiod from 30 days to 60 days and beyond. This financial penalty makesthe hospital acutely concerned for the patients' welfare post dischargeand incentivizes the Hospital to offer services outside their fourwalls, out of their own pocket, to make sure the patient is notreadmitted unnecessarily. These services today range from having a homecare agency check on the patient periodically in the 30 days and/or toassign a tele-monitor to remotely collect clinical data on the patientto try to see if a hospitalization is needed.

The use of Tele-Monitoring has been well documented for several decades.Tele-monitoring as used today is primarily a device installed in thehome with various sensors such as Blood Pressure cuffs, pulse-oximetryand weight scales that are designed to collect clinical “Vitals” of thepatient. These devices require the patient to be an active participantin the process and diligently use the device at prescribed times tocollect the data. The device then transmits the data to a centralclearing house or to a Live Ops center for action.

Tele-monitoring has been used extensively in the past to monitor“Clinical Vitals” such as pulse, blood oxygen levels, ECG, EEG etc.Tele-monitoring is usually not a wearable device but a static device ina home with various attachments that a patient needs to actively use atprescribed times by applying its various measuring devices to their body(ECG leads, pulse oximetry sensor, BP cuffs etc.). Tele-monitoringusually sends data to a LiveOps center where a nurse monitors readingsand calls a patient back for abnormal vitals results. There is noinclusion of “free” resources such as resident caregivers, family andfriends, to help determine the patient state. There is no tracking offunctional state or detecting anomalies in patterns of activity.

The adoption of Tele-monitoring has not taken off primarily due to thehigh cost of these proprietary devices and lack of reimbursement fromthe payers for installing them in a patient home. An additional hurdlehas been the requirement for active participation by the patient inusing the devices.

In the early 2000's with the widespread availability of RFID, severallarge companies (Intel, GE among others) tried to deploy the model of afully instrumented patient home with the use of ambient monitoring. Thisranged from sensors in the carpet to measure weight, to pressure matsthat detect steps, to cameras that detect presence of the patient andattempt to deduce the activity they were involved in. This overlyambitious idea failed due to several reasons: one being the very highcost of retrofitting a home for ambient monitoring systems (sensor ladencarpets, door mats, cameras, wiring, RFID tags on everyday objects andRFID readers), and a second being patient disenchantment with thesurveillance systems that reeked of “big brother” style lack of privacy.

Ambient monitoring came into vogue with the widespread use of RFID in2000. Ambient monitoring uses cameras, pressure mats, carpet sensors andRFID tags on household items to try to detect activity that a patient isengaged in. It is very expensive to fit a home with ambient monitoring.Mostly targeted towards group Senior Living Facilities, it is highlyintrusive and the lack of privacy means low adoption rates. Also,ambient monitoring has trouble distinguishing the patient from otherresidents. Wearable sensors bypass the need for ambient monitoring asthe patient is instrumented and not the home.

Wearable Sensors utilizing MEMS (Micro Electro Mechanical Systems) areubiquitous now in personal health and fitness (e.g., fitbit, Jawbone,Nike etc.). Sensors typically have Accelerometers, Gyros, Inclinometersand Magnetometers among other MEMS. Sensors can detect walking, running,sleeping, sitting, falling, and rolling among other functional states ofa wearer by combining the readings from the multiple on-board MEMS.Sensors can have radios to communicate with a base station, smartphone,computing device or directly to the internet.

Over the last 3-5 years and especially the last 12 months, there hasbeen a sharp increase in the number of health and fitness devicestargeting consumers directly. These range from wearable sensors forcounting steps, sleep state, and other fitness metrics to diseasemonitoring by use of clinical FDA approved consumer devices such asblood pressure monitors, weight scales, BMI and heart rate monitors. Onecommon aspect of these devices is that they all interact with aconsumer's Tablet, Smartphone or other computing device and presentinformation graphically to the consumer. Some also allow the data to beuploaded to a web site and either printed and shared with a clinician,or in a few cases to be sent to a Clinician's email, or in rare cases tobe sent electronically to the system the Clinician uses to store thatpatient's records. In almost all cases, these readings sit unattendeduntil the clinician and patient have another reason to interact, such asa scheduled appointment. This is because the U.S. health care system isstill based on a patient encounter between a Clinician and Patient totrigger any kind of interaction with the patient measurements.

Unlike the methods and systems of the present disclosure, other thanrecent use in fall detection, wearable MEMS sensors have not been usedpreviously in a home setting with patients. Sensors have not been usedas near real-time feedback sources in remote monitoring of directeddemonstration of activity that is disease specific. Wearable sensorshave not been used previously in a home setting with patients to trackactivity and track which room/area of a home the activity occurs in todeduce type of activity.

Further, unlike the methods and systems of the present disclosure,systems have not previously been used in conjunction with remote sensorsto predict disease progression or decline in functional status of apatient in a home setting. Systems have not been used previously to askdisease specific questions in an automated manner (previously thisrequired a clinical actor to present questions, observe patient andrecord answers). Automated systems have not been used previously to askresident care givers, family members and friends of a patient toactively participate in the observation and interrogation of a patientwith disease specific questions. Also, automated systems have not beenused to triage through all available “free” resources beforeprogressively costly resources are utilized.

Accordingly, to address the above stated issues, a method and system forremotely determining the need for healthcare interventions, and whichkeeps patients in the lowest cost setting of care, the home, for as longas possible is needed. The methods and systems disclosed herein fulfillsuch needs, and the costs and disadvantages associated with priorattempts at tele-monitoring, ambient monitoring and/or consumerself-monitoring are diminished or eliminated.

It is desired that the disclosed methods and systems for providing theabove benefits be applicable to any instances or applications wherein apatient's health is monitored to determine healthcare interventions.

SUMMARY

The exemplary technique(s), system(s) and method(s) presented hereinrelate to methods and systems for remotely determining levels ofhealthcare interventions, comprising wearable sensor technology inassociation with a computerized system utilizing a set of software anddatabases operating on a set of physical hardware in a remote location.The system monitors a patients activity and location, and determineswhen a patient who may have one or more chronic diseases or is otherwisehomebound, requires progressively higher levels of care from familymember interventions to a nurse phone call, to a medication change, to anurse visit, to a physician visits and to a hospital visit.

Most patients have varying circles of care surrounding them from aresident spouse or other family caregiver, to non-resident familymembers or friends to nurses from home care agencies to physicians andfinally hospitals. However, the first two circles of care, residentfamily caregiver and family members/friends, are not actively involvedin the chain of care today. They are passive bystanders for the mostpart even though they are the most readily available, have a vestedinterest and are in effect “free” hands and eyes in the care of thepatient. By using sensors to detect change in a patient's functionalstate or to detect changes in patterns of activities of daily living ofthe patient, the disclosed methods and systems co-opt the availablefamily caregivers or family members to act as eyes and ears to observeand report the state of the patient and to interrogate and reportanswers from the patient based on clinically established and diseasespecific questions generated by the disclosed methods and systems, aswell as general questions to establish that the state of the patient iscongruent with the system determination. This is the lowest cost steadystate both in funding and staffing for patients who are either elderlyor have a history of hospitalization or have one or more chronic careconditions.

The data from the sensors in conjunction with data observed/reported bymembers of the immediate circles of care is used to determine thelikelihood that a patient may need a higher cost clinical interventionsuch as a nurse phone call to the patient, a nurse visit to the patient,a physician appointment or communication to a physician to change meds,or ultimately hospitalization.

This conservative and progressive escalation to higher levels of care isattractive to both the ACO and MCO customers as they struggle to manageoutcomes (and thus reimbursement) as well as manage scarce resources inhuman staff. Both ACOs and MCOs prefer a low cost steady state to a highcost asymptotic event such as a hospital admission being the firstinkling that a member patient health had deteriorated. Further, thismodel wherein family resources are being activated by the System firstpromotes a caring social network around a patient that could foster abetter quality of life. Previously, family members and friends were onlyaware post an adverse event and could not help prior to that, as theywere more likely not aware of the gradual decline that the System is nowable to detect and warn.

Accordingly, it is an object of the methods and systems disclosed hereinto function as an early warning system to all persons involved with apatient, including the ACO/MCO, that a patient degradation is underwayand to help trigger proportionately increasing levels of interventionsto return the patient to positive outcomes.

It is another object of the methods and systems disclosed herein toutilize the lowest cost resources, for instance technology and “free”eyes and ears in terms of resident caregivers or non-resident familymembers and friends, in its capacity as a sentinel or early warningsystem that only progressively escalates to higher cost interventions.

It is another object of the methods and systems disclosed herein toutilize passive monitoring of functional state and detection of activitypatterns and deviations as an indicator of health state, and to co-optthe caregivers around a patient into being the remote “eyes and ears” incollecting additional data and validating the determination for care.

It is another object of the methods and systems disclosed herein toutilize an unobtrusive sensor that is worn on the body and whichintegrates room/area identification, to allow the system to deduceactivity the patient maybe involved in without encroaching on theirprivacy.

It is another object of the methods and systems disclosed herein to usethe readings from the wearable sensor to drive immediate automatedanalysis and activate the different levels of care surrounding a patientto get additional information, to confirm predicted trends, andultimately be an early warning system that raises an alert to aClinician before the patient deteriorates too far to be managed costeffectively.

It is another object of the methods and systems disclosed herein toutilize a sentinel system in conjunction with patient education onwellness and management of their disease through healthier life styles.

Additional objects, advantages and novel features will be set forth inpart in the description which follows, and in part will become apparentto those skilled in the art upon examination of the following and theaccompanying drawings or may be learned by production or operation ofthe examples.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawing figures depict one or more implementations in accord withthe present teachings, by way of example only, not by way of limitation.In the drawing figures, like reference numerals refer to the same orsimilar elements.

FIG. 1 is a block diagram of the components of the sensor of anexemplary embodiment of the system of the present disclosure.

FIG. 2 is a block diagram of an exemplary embodiment of the system ofthe present disclosure.

FIG. 3 is a flow chart of the overall setup and installation of anexemplary embodiment of the method and system of the present disclosure.

FIG. 4A is a flow chart for the system configuration for a patient of anexemplary embodiment of the method and system of the present disclosure.

FIG. 4B is a flow chart for the system configuration for a patient,continued from FIG. 4A, of an exemplary embodiment of the method andsystem of the present disclosure.

FIG. 5 is a flow chart for the infrared beacon setup and installation ofan exemplary embodiment of the method and system of the presentdisclosure.

FIG. 6 is a flow chart for the base station setup and installation of anexemplary embodiment of the method and system of the present disclosure.

FIG. 7 is a flow chart for the sensor setup and installation of anexemplary embodiment of the method and system of the present disclosure.

FIG. 8 is a flow chart for the sensor fitting on a patient of anexemplary embodiment of the method and system of the present disclosure.

FIG. 9 is a flow chart for the software application installation andconfiguration on computing devices of an exemplary embodiment of themethod and system of the present disclosure.

FIG. 10 is a flow chart for the sensor operation of an exemplaryembodiment of the method and system of the present disclosure.

FIG. 11 is a flow chart for the system steady state of an exemplaryembodiment of the method and system of the present disclosure.

FIG. 12 is a flow chart for the patient contact intervention level of anexemplary embodiment of the method and system of the present disclosure.

FIG. 13 is a flow chart for the resident caregiver contact interventionlevel of an exemplary embodiment of the method and system of the presentdisclosure.

FIG. 14 is a flow chart for the non-resident family/friend contactintervention level of an exemplary embodiment of the method and systemof the present disclosure.

FIG. 15 is a flow chart for the clinical contact intervention level ofan exemplary embodiment of the method and system of the presentdisclosure.

DETAILED DESCRIPTION

The following description refers to numerous specific details which areset forth by way of examples to provide a thorough understanding of therelevant method(s) and system(s). It should be apparent to those skilledin the art that the present disclosure may be practiced without suchdetails. In other instances, well known methods, procedures, components,and circuitry have been described at a relatively high-level, withoutdetail, in order to avoid unnecessarily obscuring aspects of the presentdisclosure. While the description refers by way of example to methodsand systems for determining healthcare interventions, it should beunderstood that the method(s) and system(s) described herein may be usedin any situation where a patient's health is monitored.

As discussed in more detail below, the system comprises a wearablesensor, a plurality of infrared beacons, and a communication system inassociation with a computerized system utilizing a set of software anddatabases operating on a set of physical hardware in a remote location.The system utilizes passive monitoring of the functional state of apatient, and detection of activity patterns of a patient, and deviationsthereof, to determine the health state of a patient. The system utilizesthis health state determination to co-opt the various levels ofcaregivers around a patient to collect additional data and validate thedetermination for care.

The system is configured for the patient with a set of data. Forexample, including but not limited to, diseases present, patientaddress, contact info, availability and types of computing device foruse by patient, availability and number of telephone for use by patient,family caregiver contact info and computing device info, family memberscontact info and computing device info, ACO affiliation, MCOaffiliation, Hospital affiliation, Physicians of record, Case manger ofrecord, Geriatric counselor of record, Pharmacies and contact info,Insurance info, type of residence, number of rooms, type of each room,base station type, communication medium and its configuration, number ofbeacons, type of beacons.

The home the patient lives in maybe equipped with low power infraredbeacons (“Beacon”) which transmit a unique ID representing the area of ahome they are affixed in. For example Stove/Kitchen, Toilet/Bathroometc. These are self installed devices that are fixed at a range ofprescribed heights and operate on self contained power or utility power.

The patient wears a wearable sensor apparatus, which is worn on thebody. The placement of the Sensor may range from head, neck, chest,waist, upper hand, forearm, the wrist, hand, upper or lower thigh orlower extremities and the ideal placement may be recommended based onthe disease state and physical ability and condition of the Patient. TheSensor may be worn under certain types of clothing as well that allowsinfrared beams to pass through. The Sensor may have one or moreadjustable band, bracelet, strap, lanyards to allow it to be worn. TheSensor may be constructed to be liquid proof or liquid resistant

FIG. 1 is a block diagram of the components of the sensor of anexemplary embodiment of the system of the present disclosure. As can beseen in FIG. 1, the Sensor contains various sensing devices such as, oneor more Gyros, Accelerometers, Magnetometers, Inclinometers,Thermometers, and/or Galvanic Skin Response (GSR) sensors to detect themotion and state of the person and direction of travel/orientation ofperson wearing it. The Sensor also includes one or more Infraredreceivers, or other suitable types of receivers, capable of sensingexternal infrared beams, or other suitable types of transmissions, anddecoding the data embedded therein. The infrared receivers contained inthe Sensor are capable of discriminating among multiple infrared beamsand deducing the strength of the beam and thus the distance to the beamtransmitter. One or more of the infrared receivers may be arranged onthe Sensor to assist in beam triangulation to increase accuracy indetermining direction, strength and distance to the beam transmitters.

Additionally, the Sensor contains a processing unit, memory and storageas required for a computing device. The Sensor runs operating systemsoftware and application software that allows the Sensor to beprogrammed to perform actions based on events. The Sensor may containone or more radios such as a WiFi radio, a Bluetooth radio, a cellulardata modem radio, a Zigbee radio, a XBee radio. The Sensor may containone or more interface ports for the Sensor to be programmed, tested,charged or for data to be communicated into or out of the Sensor. TheSensor contains one or more fixed or removable power sources to operateindependently of external power. The Sensor may contain one or morecharging ports to charge the internal power source. The Sensor maycontain one or more induction charging circuits for the internal powersource to be charged using a charging surface such as a charging mat,charging dongle, and/or charging cradle. The Sensor may contain one ormore indicators to inform the user visually or aurally of the state ofthe charge within the internal power source.

The Sensor may also contain one or more output devices to conveyinformation such as lights, vibration motors, display units, and/orspeakers. The Sensor may contain one or more input devices to interactwith the user such as microphones, buttons, and touch sensors. TheSensor may also employ its internal sensing devices to interact such asfor example single tap on the device to display visually or aurally thebattery level or double tap to cause it to synchronize data outside itsnormal schedule.

Still further, the Sensor may employ various sensing devices such as oneor more capacitance sensors, skin electrodes, pressure sensors, magneticswitches and/or mechanical switches, to assist in detecting when it isbeing worn. The Sensor can record and report when it is not being wornand can report data related to how often it is being worn and how oftenit is not. The Sensor can make deductions on the activity and posture ofthe patient (e.g., sleeping, sitting, reclining, prone, supine, walking,running, shuffling, and/or falling). The Sensor can determine whichlocal area (room) of a structure (home) or a specific area (Toilet)within a local area (Bathroom) of a structure (home) the patient isproximal to by means of an infrared receiver receiving the signals fromthe Beacon and deducing the location by the IDs of the one or morebeacons visible to the infrared receiver(s).

The Sensor can determine which activity the patient is engaged in by thecombination of the functional activity type (e.g., walking, sitting,reclining, standing, and/or lying down) and the area/room they are inwhen performing such activity. For instance, when the room detected is abathroom and posture detected is sitting, this may indicate with a highlikelihood that the person is using the toilet.

The Sensor may contain one or more internal clocks to provide time baseand time reference. The Sensor aggregates data from its sensing devicesand timestamps all data. The Sensor deduces activity of the patientbased on the aggregation of the data from its sensing devices. TheSensor is capable of storing onboard, information deduced from thesensing devices readings and worn status.

The Sensor periodically checks to see if a connection is available tothe internet either via a Base Station (if one is configured), orthrough a smart phone (if one is configured), a WiFi network (if one isconfigured), an onboard or outboard cellular data modem (if one isconfigured or is present onboard). If a base station is configured, theSensor may communicate to it using a low power short range radiofrequency protocol such as Bluetooth, Zigbee, XBee or WiFi. If asmartphone is configured, the Sensor may communicate to it using a lowpower short range radio frequency protocol such as Bluetooth, NFC, orWiFi. If an outboard cellular data modem is configured, the Sensor maycommunicate to it using a low power short range radio frequency protocolsuch as Bluetooth, NFC, or WiFi. If an onboard cellular data modem isconfigured, the Sensor may communicate to it using internal busprotocols such as i2c, NXP, Serial or other internal intra-component,intra circuit board or inter component and inter circuit boardprotocols. The Sensor periodically communicates via the Internet anduploads data into one or more databases and software systems (“System”)at a remote location.

It is foreseen that the sensor and or system can be integrated with orto various other sensors such as Blood Pressure cuffs, pulse-oximetry,weight scales, sensors for counting steps, sleep state, and otherfitness metrics, blood pressure monitors, BMI and/or heart ratemonitors. The system can consume the readings from one or more of thesedevices to add data points to its prediction analysis.

FIG. 2 is a block diagram of an exemplary embodiment of the system ofthe present disclosure. The System is comprised of a set of software anddatabases operating on a set of physical hardware in a remote location.The System can send and receive data through the Internet to Sensors,Base Stations, other Devices such as but not limited to patientself-monitoring devices, other Systems, Computing devices, web sites,and Smartphones. The System can be accessed by various persons via theInternet using a web browser, and System presents information relevantto the person viewing it. The System can send and receive data to andfrom one or more Sensors worn by one or more Patients. The System cansend and receive data to and from Software Applications running oncomputing devices such as but not limited to Smart Phones, Tablets andComputers. The System stores the received data into one or moredatabases. The System can communicate with multiple other Systems,Devices and Communications networks.

The System actively monitors usage data sent by the Sensor (being wornor not), and can initiate notifications in a progressively escalatingmanner if the device is not being used as intended. The System creates abaseline for activity using the first n days of received data, where nis configurable. The received data may originate from, but is notlimited to, the Sensor, Other Systems, Consumer Devices, responses toquestions on configured computing devices of resident family caregiver,non-resident family members, patient, Telephone IVR, clinicians, liveops center, physician, hospital and/or diagnostic labs.

The System analyzes the data and applies various algorithms based on butnot limited to: a) one or more diseases of the person (e.g., CHF,Diabetes, Hypertension COPD, etc.); b) deduce functional level by howmuch activity the patient is engaged in; c) analyze for changes inactivity pattern from previously learned patterns of activity; d) deducefrom the data such as change in gait, number of steps taken, amount ofactivity, etc., if the person is degrading; e) deduce if the person hasfallen by applying an algorithm to the sensor accelerometer data,room/area the person is in, position of the person now (e.g., supine,prone, reclining, etc.), and length of time with limited motion,repeated motions to achieve a standing position, crawling motions, andif body position is appropriate normally for the room/area person is nowin.

The System sends a notification to the patient's configured computingdevice (Tablet/Phone/Computer) if one is configured. The notificationwill cause the application on the computing device to present specificquestions. These questions will be based on the disease state of thepatient and are well established in the academia as to their predictivevalue. The questions may have an interrogatory component where the appposes questions to the patient and accepts their responses. The systemgathers the responses from the local application and adds them to itsdatabase(s). The software then analyses the additional data to see ifescalation to next level, status quo, or de-escalation is appropriate.If the patient does not answer or respond to the application prompts,the System may escalate to the next level of care.

Based upon the sensed information, the System can additionally ask thepatient to demonstrate a disease specific activity such as “walk twentysteps,” and use the sensor to detect demonstration of the activity, timetaken to complete activity, and/or vital signs before, during and afterthe activity, etc., and at its completion ask follow-up questions basedupon the sensed information, such as “are you short of breath,” etc. Thesystem stores the responses for analysis and scoring according toestablished clinical guidelines. Thus, the system, based upon itsanalysis of sensed information, can automatically initiate patient tasksor tests, physical and/or mental, and evaluate patient performance ofthese tasks or tests in real-time.

If the patient is not capable of using a computing device, the System isconfigured to cause a telephone IVR system to call the patient. TheTelephone IVR system will ask questions of the Patient such as forexample “Press 1 if you are feeling pain”, “Press 2 if you took yourmeds today”, “Press 3 if you had a bowel movement”, “Press 4 if you arefeeling short of breath”, and/or “Press 5 if your ankles are swollen”.These questions will be based on the disease state of the patient andare well established in the academia as to their predictive value. TheSystem gathers the responses from the IVR system and adds them to thedatabase(s). The System then analyzes the additional data to see ifescalation to next level, status quo, or de-escalation is appropriate.

The software, depending on the analysis of sensed information and/orresponses to questions, sends a notification to the configured computingdevice of a resident caregiver who is in the same home as the Patient.(First level of the “Circles of Care”). The notification will cause theapplication on the computing device to present specific questions. Thesequestions will be based on the disease state of the patient and are wellestablished in the academia as to their predictive value. The questionswill have an observational component where the resident caregiveranswers questions on the observed state and behavior of the patient. Theother questions will have an interrogatory component where the residentcaregiver poses questions to the patient and enters their responses. TheSystem gathers the responses and adds them to the database(s). TheSystem then analyzes the additional data to see if escalation to nextlevel, status quo, or de-escalation is appropriate.

The software, depending on the analysis of sensed information and/orresponses to questions, sends a notification to the configured computingdevice of the next level of non-resident family members (siblings,sons/daughters, etc., who may not be residing in the same vicinity aspatient) and/or friends. (Second level of the “Circles of Care”). Thenotification will cause the application on the computing device topresent specific questions. These questions will be based on the diseasestate of the patient and are well established in the academia as totheir predictive value. If the family member or friend is physically inthe same vicinity as the patient (the application provides the choice onwhether they are physically with the patient) then the questions willhave an observational component where the family member or friendanswers questions on the observed state and behavior of the patient. Theother questions will have an interrogatory component where the familymember or friend poses questions to the patient and enters theirresponses. The System gathers the responses and adds them to thedatabase(s). The System then analyzes the additional data to see ifescalation to next level, status quo, or de-escalation is appropriate.

If escalation is required based on all the data gathered thus far, thesoftware sends a notification to the configured computing device(s) at aLive Ops center or other computing device where trained nurses or otherclinical contacts review the data, call the Patient and/or residentfamily caregiver and/or other family members or friends. (Third level ofthe “Circles of Care”). The notification may cause the Nurse to call thepatient with specific clinical questions based on their diseases,functional status, observed and reported state. The notification maycause the Nurse to call the resident caregiver with specific questionsbased on the patient diseases, functional status, observed and reportedstate. The notification may cause the Nurse to call the non-residentfamily member or friend with specific questions based on the patientdiseases, functional status, observed and reported state. The systemgathers the responses and adds them to the database. The Nurse is thenoffered a choice to escalate to next level, maintain status quo, orde-escalate to a lower level.

If escalation is chosen, the Nurse can escalate to the next necessary ordesired step(s), which may be an in person visit, consult with physicianto change medication, schedule a physician appointment for the patient,or arrange for hospitalization. (Fourth level of the “Circles of Care”).All stakeholders in the 1st-3rd levels of the “Circles of Care” arenotified of escalation. If Status Quo is chosen, all stakeholders in the1st-3rd levels of the “Circles of Care” are notified of status quo andoptionally additional instructions on what changes in patient state tolook for. A follow-up (notification) to 1st-3rd levels is scheduled bythe system to ask follow-up questions identified by the nurse. Ifde-escalation is chosen, all stakeholders in the 1st-3rd levels of the“Circles of Care” are notified of de-escalation and optionallyadditional instructions on what changes in patient state to look for.

FIG. 3 is a flow chart of the overall setup and installation of anexemplary embodiment of the method and system of the present disclosure.As can be seen in FIG. 3, the overall system can be set up and installedin six steps, in the exemplary embodiment illustrated. In Step A, thesystem is configured for a patient, as illustrated in FIGS. 4A and 4Bdiscussed below. In Step B, the Infrared Beacons are set up andinstalled, as illustrated in FIG. 5 discussed below. In Step C, the BaseStation is set up and installed, as illustrated in FIG. 6 discussedbelow. In Step D, the Sensor is set up and installed, as illustrated inFIG. 7 discussed below. In Step E, the Sensor is fitted on the patient,as illustrated in FIG. 8 discussed below. In Step F, the applicationsoftware (App) is installed and configured on computing devices usedwith the system, as illustrated in FIG. 9 discussed below.

Referring to FIGS. 4A and 4B, a flow chart for the system configurationfor a patient is disclosed. The system configuration for a patientpreferably comprises the following steps: setup a patient unique ID andpassword; enter patient demographics, computing device information ifpresent, and telephone for IVR if present; enter patient diseases,medications, and diagnosis, and patient baseline health vitals (height,weight, pulse, blood pressure etc.); enter Resident Caregiver(s)demographics, computing device info if present, and telephone for IVR ifpresent; enter Non-resident Family member(s) and/or friendsdemographics, computing device info if present, and telephone for IVR ifpresent; enter Sensor information; enter Base station information ifpresent; enter patient ACO information if present; enter patient MCOinformation if present; enter patient pharmacy information if present;enter patient doctor information; enter patient hospital information ifpresent; setup patient case manager demographics; setup patientgeriatric counselor demographics if present; setup patient residencetype, number of rooms, areas configured; set up infrared beacon typesand number to be configured; and setup patient social network feeds andaccess information if desired.

Referring to FIG. 5, a flow chart for the infrared beacon setup andinstallation is disclosed. The infrared beacon setup preferablycomprises the following steps: install battery in the infraredbeacon(s); if the beacon is configurable, then configure the beacon forroom/area by setting DIP switches or code wheel; affix the beacon in theroom/area it is labeled for; and test the beacon reception, range andcoverage.

Referring to FIG. 6, a flow chart for the base station setup andinstallation is disclosed. The base station setup and installationpreferably comprises the following steps: determine location andphysically install; select system connection type and configure; testsystem connection; if the system connection did not pass the test, thentroubleshoot and repeat Steps A-C.

Referring to FIG. 7, a flow chart for the sensor setup and installationis disclosed. The sensor setup and installation preferably comprises thefollowing steps: charge and/or install power source; if the base systemis available, then pair the sensor with the base system; if the basesystem is not available, the configure the sensor to communicate withthe system; test the sensor communications to the system; and if thesensor communications did not pass the test, then troubleshoot andrepeat steps C-D.

Referring to FIG. 8, a flow chart for the sensor fitting on the patientis disclosed. The sensor fitting on the patient preferably comprises thefollowing steps: determine sensor location on the patient based upon thedisease information of the patient; train patient, resident caregiverand non-resident family member or friend, if available, on sensor careand usage; have patient perform activities to verify sensor operation;if the system does not properly register patient activity, thentroubleshoot and repeat Steps C-E.

Referring to FIG. 9, a flow chart for the software applicationinstallation and configuration on computing devices is disclosed. Thesoftware application installation and configuration on computing devicespreferably comprises the following steps: if a patient computing deviceis available, then determine if the device is compatible with thesystem, and if compatible, install the software application on thepatient device and configure; if a resident caregiver computing deviceis available, then determine if the device is compatible with thesystem, and if compatible, install the software application on theresident caregiver device and configure; and if a non-resident familymember or friend computing device is available, then determine if thedevice is compatible with the system, and if compatible, install thesoftware application on the non-resident family member/friend device andconfigure.

FIG. 10 illustrates a flow chart for the operation of the sensor of themethod and system of the present disclosure. Specifically, when thesensor detects an event, such as new motion, change of state in motion,patient inclination, G-force, patient direction orientation, infraredbeacon data received, etc., the sensor stores the sensed motion datawith timestamp. The sensor then detects the motion event type, such aswalking, sleeping, falling, sitting, shuffling, running, rolling, etc.,and stores the sensed motion type data with timestamp. The sensor alsodetects the room/area where the motion event is occurring in and storesthe room/area data with timestamp. The sensor next deduces the nature ofthe activity and stores the nature of activity data. If systemcommunications are available, then the sensor sends the stored data, andany previously unsent stored data if available, to the system. If systemcommunications are not available, the sensor clock timer is set, andsubsequently triggers the sensor to check if communications areavailable to send unsent data.

FIG. 11-15 illustrate flow charts for the operation of the system of themethod and system of the present disclosure. Specifically, FIG. 11 is aflow chart for the system steady state. When the system receives datafrom the sensor (step 1A), the system analyzes the data that isreceived, and based upon the data received and the analysis thereof,determines what level of healthcare intervention is required. If thesystem determines that the patient requires a first level ofintervention, then the system initiates the patient contact step 2A,illustrated in FIG. 12. If the system determines that the patientrequires a second level of intervention, then the system initiates theresident caregiver contact step 3A, illustrated in FIG. 13. If thesystem determines that the patient requires a third level ofintervention, then the system initiates the non-resident family memberor friend contact step 4A, illustrated in FIG. 14. If the systemdetermines that the patient requires a fourth level of intervention,then the system initiates the clinical contact step 5A, illustrated inFIG. 15.

FIG. 12 illustrates a flow chart for the patient contact interventionlevel (step 2A) of the method and system of the present disclosure. If apatient computing device is configured, then the system triggersnotification on the patient computing device, discussed above withrespect to FIG. 2. If the patient responds, then the patient computingdevice sends response data to the system, which proceeds back to step1A. If the patient does not respond, then the system proceeds to step3A. If a patient computing device is not configured, then the systeminitiates a telephone IVR call, discussed above with respect to FIG. 2.If the patient responds, then the IVR sends response data to the system,which proceeds back to step 1A. If the patient does not respond, thenthe system proceeds to step 3A.

FIG. 13 illustrates a flow chart for the resident caregiver contactintervention level (step 3A) of the method and system of the presentdisclosure. If a resident caregiver computing device is configured, thenthe system triggers notification on the resident caregiver computingdevice, discussed above with respect to FIG. 2. If the residentcaregiver responds, then the resident caregiver computing device sendsresponse data to the system, which proceeds back to step 1A. If theresident caregiver does not respond, then the system proceeds to step4A. If a resident caregiver computing device is not configured, then thesystem initiates a telephone IVR call, discussed above with respect toFIG. 2. If the resident caregiver responds, then the IVR sends responsedata to the system, which proceeds back to step 1A. If the residentcaregiver does not respond, then the system proceeds to step 4A.

FIG. 14 illustrates a flow chart for the non-resident family member orfriend contact intervention level (step 4A) of the method and system ofthe present disclosure. If a non-resident family member or friendcomputing device is configured, then the system triggers notification onthe non-resident family member or friend computing device, discussedabove with respect to FIG. 2. If the non-resident family member orfriend responds, then the non-resident family member or friend computingdevice sends response data to the system, which proceeds back to step1A. If the non-resident family member or friend does not respond, thenthe system proceeds to step 5A. If a non-resident family member orfriend computing device is not configured, then the system initiates atelephone IVR call, discussed above with respect to FIG. 2. If thenon-resident family member or friend responds, then the IVR sendsresponse data to the system, which proceeds back to step 1A. If thenon-resident family member or friend does not respond, then the systemproceeds to step 5A.

FIG. 15 illustrates a flow chart for the clinical contact interventionlevel (step 5A) of the method and system of the present disclosure. Inthis level of intervention, the system triggers notification on theclinical contact web dashboard or computing device. The clinical contactthen can initiate calls to and or amongst the patient, the residentcaregiver, the non-resident family member or friend, or the patient'sdoctor to obtain additional information, discussed above with respect toFIG. 2. Based upon the information gathered, the clinical contact canschedule a doctor visit, admit the patient to a hospital, communicatechanges in medication or prescription of new medications and notify thepharmacy and the patient, etc. The clinical contact updates the systemwith all of the new data and information, and the system then proceedsback to step 1A.

Accordingly, from the above description, it can be seen that thedisclosed methods and systems keep the patient in the lowest cost caresetting, the home, and use a sentinel system utilizing wearable sensorstechnology to determine when functional state is declining or patternsof activity change and trigger progressively higher levels ofintervention, from “free” hands and eyes to skilled clinicians.

The Sensor and infrared beacon, or other room identifying devices,together allow for the detection of the room/area in which the patientactivity is taking place. Thus, the Sensor detects not just the type ofactivity but where it is taking place so deductions can be made. Forexample, if the sensor detects a sitting posture and the room/area asBathroom, the system can infer that the patient is using the toilet. Ifthe sensor senses that the patient is standing and taking small steps,and room/area detected is the Kitchen, the system can infer that thepatient is preparing food or drink. The sensor helps the system build abaseline of activity and also a “normal” pattern of daily behaviors foreach patient.

The system can determine if the patient's functional state is declining.For example, the system can determine that a patient normally wakes upat 7:30 AM and walks on average 300 steps by 8 AM, but has now startedwalking far less in the same time. The system can also determine changesin a patient's pattern of activities. For example, the system candetermine that a normal pattern of activity for a patient is to go fromBedroom to Bathroom, spend 20 minutes, go to Kitchen spend 10 minutesand then sit in the Living Room for the rest of the morning, but todaythe patient went from Bedroom to Bathroom and back to Bedroom where thepatient stayed the whole morning in a prone position.

The system can determine additional data points on the progression ofthe disease state by presenting Observatory and Interrogatory questionsto the Patient and others. The system can determine additional datapoints by prompting the patient to perform certain activities that aredisease specific (for example: walk 10 steps) and then measuring theactual demonstrated activity and timing in real-time or near real-timevia the sensor, as well as ask disease specific follow-up questions atthe end of demonstration such as “are you short of breath” to furthercorroborate analysis.

When a pattern change or decline in functional activity is noticed, thesystem contacts the patient. The patient is contacted either via an App(if they are capable) or via Telephone IVR. The patient is askedquestions that may encompass general, emotional state as well as diseasespecific. The questions are stored in the systems database(s) and areformed from established clinical guidelines (for example SeattleObstructive Lung Disease Questionnaire, or SOLDQ in the case of a COPDpatient), and responses are scored. The System can prompt the patient toperform a series of activities as part of the questionnaire and theSensor can monitor and report back to the System in real-time or nearreal-time.

If a patient cannot be contacted or additional data points are needed,the system triggers the First Circle of Care: The Resident Caregiver(RC) if one is present (e.g., Spouse, Partner, Friend/roommate) iscontacted either via an App (if they are capable) or via Telephone IVR.The RC is presented with questions they can answer by observing thepatient. The RC is presented with questions that they can ask Patient(interrogatory component) and report answers back to the system. Thequestions asked are disease specific and based on establishedquestionnaires in academic research.

If additional data points are needed, the system triggers the SecondCircle of Care: The Non-Resident Family member or Friend (NRF) if one ispresent (e.g., Sibling, Adult Children, Friends) are contacted eithervia an App (if they are capable) or via Telephone IVR. The NRF ispresented with questions they can answer by observing the patient. TheNRF is presented with questions that they can ask Patient (interrogatorycomponent) and report answers back to the system. The questions askedare disease specific and based on established questionnaires in academicresearch.

If analysis warrants further escalation, the system triggers the ThirdCircle of Care: The Clinical Contact (CC) at an ACO, MCO or LiveOpsCenter is contacted either via an App (if they are mobile) or via a webdashboard. The System displays patient history, its analysis thus far,questions and responses and scoring of answers from the Patient, RC andNRF as well as normal baseline functional scores and patterns ofactivity versus current observed anomalies for review. The CC reviewsdata and determines next course of action.

The CC uses human intelligence to determine the next appropriate courseof action which maybe one or more of: Call Patient or RC or NRF togather additional data; Dispatch a nurse/therapist for an onsite visitto verify clinical condition or perform a clinical intervention; ContactMD to review patient history and current state; Determine if change inmedications or new medications are needed, and contact Pharmacy andPatient as needed; Schedule an office visit with MD if appropriate;and/or Schedule a hospital admission if appropriate. The CC then updatesthe System with all actions taken and any other relevant information.

Example of System in Use

The following narrative represents a hypothetical Use Case scenarioillustrating the methods and systems of the present disclosure in use:

Mr. Jones is an 85 year old male patient in Florida. Mr. Jones lives athome with his spouse, 75 year old Mrs. Jones, who is of reasonablehealth. Mr. Jones is a Medicare beneficiary. The Jones have their sonSam, 48 years old, living 5 miles away and another son, Kyle, living inCalifornia. In addition, Mr. Jones close friend Mr. Pablo lives nextdoor.

The Jones lives in a condo that has one bathroom, a living room, abedroom, a kitchen and a dining room. The home has Internet access andMrs. Jones is an avid user of a tablet computer. The Jones have a landline phone and a cell phone that Mrs. Jones carries. Sam and Kyle areavid users of smartphones and tablet computers. Mr. Pablo uses hisdesktop computer primarily to browse the Internet and to keep in touchwith his family via email and social media.

Mr. Jones was diagnosed with a chronic care condition of ChronicObstructive Pulmonary Disease (COPD) 5 years ago. Mr. Jones has beenhospitalized for his condition several times. Mr. Jones uses a regimenof medication to manage his chronic disease. Mr. Jones was most recentlydischarged from the hospital a few days ago. At his discharge theHospital and MD prescribed use of the disclosed system at no cost to Mr.Jones.

The hospital entered all of Mr. Jones information including hisdemographics, disease, etc., Mrs. Jones contact information, Sam andKyle's information, as well as Mr. Pablo's information among others,into the system. A wearable sensor was fitted on Mr. Jones leg at hisdischarge and a self-install kit of five Infrared (IR) beacons labeled“Kitchen”, “Bathroom”, Living Room”, “Dining Room”, “Bedroom” wereprovided to him, as well as a charger and a Base station withinstructions on installation. Mr. Jones' son, Sam, came by to affix thesmall beacons in the respective rooms following the instructions onplacement. The charging plate was installed by Mr. Jones' bed side, andMr. Jones was instructed on removing the sensor and placing it on thecharger plate for recharging when the sensor indicated that its batterywas running low.

The base station was then plugged in and the Sensor was tapped threetimes to communicate with the base station and perform a communicationssystem check. The Sensor green LED lit to indicate success, and then Mr.Jones, following the installation instruction, walked into each of theseparate rooms in turn. In each room, the sensor detected the distinctroom by detecting the infrared beam and decoding the room ID containedin the beam for the specific room Mr. Jones was in, and vibrated and litits green LED to indicate success.

The System sends Mrs. Jones a link to install Apps on her tabletcomputer, which she does successfully. The System sends Sam and Kyle alink to install Apps on their tablet computers and smartphones, whichthey successfully do. The System sends Mr. Pablo a link to install Appson his desktop computer, which he does successfully.

Day 1-7: The sensor monitors Mr. Jones' activities over an initialperiod, for example seven days to create a baseline of normal activityand to note patterns of behavior. It determined on average that Mr.Jones woke up each day at 5:30 AM and walked about 250 steps in the 60minutes. It noted that Mr. Jones went from the bedroom upon waking tothe bathroom (taking about 30 seconds), where he spent 15 minutes andthen he went to the kitchen where he spent 5 minutes and then went tothe living room and sat for 2 hours. At about 8:00 AM, Mr. Jones wentout of the condo (lack of IR signals, loss of connectivity to the basestation) and walked for 30 minutes and then came back to the condo(detection of IR beams, regaining base station connectivity). Uponcoming back in range the sensor transmitted the activity details thatoccurred when the sensor was out of range of the base station.

Day 7-14: The sensor continues to monitor Mr. Jones and no statisticallysignificant variances in functional level or change in patterns ofactivity is detected by the system.

Day 15: The sensor detects normal pattern of activity but also that Mr.Jones is taking longer (but not statistically significant) to walk thesame distances.

Day 16: The sensor detects variations in normal pattern of activity andthat Mr. Jones is taking longer to walk the same distances (but neitheris statistically significant). The system sends a push notification toMrs. Jones and she responds on her app to several questions generated bythe system from its databases based upon the sensed information:

-   -   a. Is Mr. Jones walking normally?—Yes    -   b. Is he shuffling?—No    -   c. Does he seem out of breath?—Yes    -   d. Is he eating normally?—Yes

The system records Mrs. Jones' responses for subsequent analysis.

Day 17: The sensor detects a normal pattern of activity, but also astatistically significant longer time to cover the same distances. Thesystem calls Mr. Jones through its IVR telephone system and has himanswer several questions:

-   -   a. Are you feeling short of breath?    -   b. Are you breathing heavily?    -   c. Have you been practicing the energy conservation techniques        taught at discharge?    -   d. Do you have any pain?    -   e. Are you feeling tired?

Based on Mr. Jones responses, the System sends a notification to Mrs.Jones and her App prompts her to answer some observational questionsabout Mr. Jones.

-   -   a. Is Mr. Jones breathing laboriously?—Yes    -   b. Was he snoring last night?—Yes    -   c. Does he seem tired?—Yes    -   d. Is his face puffy?—Yes    -   e. Are his ankles swollen?—No

The system records Mr. Jones' responses, and Mrs. Jones' responses forsubsequent analysis.

Day 18: The sensor detects Mr. Jones waking up at 6:30 AM, goes to thebathroom for 10 minutes, then to the Kitchen and then Living room butreturns to the bedroom where he lies down again for the next one hour.He has only taken 100 steps when normal activity is 250 steps. It alsonotes that the time taken to go from the bedroom to the bathroom is 60seconds, statistically longer than the 30 second normal time. Sensorcommunicates this data to the System. The System determines an anomalyis occurring.

Since Mr. Jones does not use a computer, the System initiates an IVRTelephone call to the land line of the Jones residence. Mr. Jones picksup the phone and System identifies itself. The System prompts Mr. Jonesto “Press 1 if Mr. Jones is available to speak” or Press 2 for No. Mr.Jones presses 1. The System explains the reason for call: “we note thatyou did not follow your normal routines this morning.” The System asks“Are you feeling unwell?” Press 1 for Yes, 2 for No. Mr. Jones respondswith 1. The System then asks “Do you feel up to answering a fewquestions?” Press 1 for Yes, 2 for No. Mr. Jones responds with 2. TheSystem then says, “Ok, please let Mrs. Jones know that we will contacther for some follow-up questions” and hangs up.

System next sends a push notification to Mrs. Jones tablet app. Mrs.Jones opens the App and the System notifies Mrs. Jones that: “We arecontacting you as Mr. Jones seems unwell and we'd like to ask for yourassistance in determining how he is feeling.” The App requests Mrs.Jones to observe Mr. Jones and answer several observational questions:

-   -   a. Is Mr. Jones ankles swollen?    -   b. Is his skin color pale or normal?    -   c. Does he have a fever?    -   d. Is he coughing?    -   e. Does he seem short of breath?    -   f. Is he breathing heavily?    -   g. Did he eat normally last night?    -   h. Did he eat anything unusual last night?

After receiving responses to these questions, the App then asks Mrs.Jones to pose several interrogatory questions to Mr. Jones and enter hisresponses in the app. Specifically, in this scenario, the interrogatoryquestions are twenty questions from the Chronic Respiratory DiseaseQuestionnaire (CRDQ) questionnaire to determine Dyspnea, Fatigue,Emotional burden and mastery of the disease. CRDQ is designed to beadministered by an interviewer. All are multiple choice format andwritten for easy comprehension. Based on the entered responses, thesystem finds Mr. Jones' responses to the questions related to theemotional function to be outside the normal range.

The System then sends a push notification to Sam, Kyle and Mr. Pablo'scomputing devices, informing them of Mr. Jones' status, and optionallyrequesting that they take a desired action or respond to furtherquestions. Sam decides that he will stop by on his way to work the nextday to see how his dad is doing. Kyle is travelling and decides thatwhen he gets home two days hence he will call Dad to see how he isdoing. Mr. Pablo responds to the notification and walks over next doorto Mr. Jones home to see how he is doing and “boost his spirits”. Hebrings with him the newspaper to read stories to his friend and engagehim. The Sensor detects in the meantime that Mr. Jones has visited thebathroom several more times during the day but is still going back tolie down. Mr. Jones has his dinner and goes to sleep.

Day 19: Mr. Jones wakes up the next day at 6:30 AM and walks to thebathroom, kitchen and then back to the bedroom. The System notes furtherdecline in activity and larger change in pattern of normal behavior. TheSystem triggers another notification to Mrs. Jones, Sam and Kyle. Samstops by in the morning and the app on his smartphone prompts him torespond to a few observational questions:

-   -   a. Is Mr. Jones ankles swollen?    -   b. Is his skin color pale or normal?    -   c. Does he have a fever?    -   d. Is he coughing?    -   e. Does he seem short of breath?    -   f. Is he breathing heavily?    -   g. How is his mood?

The App asks Sam to see if he can encourage his Dad to take a 6 minutewalk test. Mr. Jones says Ok. Mr. Jones commences walking and the App onSam's smartphone times him, while the sensor measures how many steps hehas taken in the 6 minutes. However, Mr. Jones is unable to complete thetest and stops after 1 minute. Sam is then prompted to ask Mr. Jones afollow-up question on if he is feeling short of breath and his responseis entered. System determines that based on responses thus far, a nursecall is needed.

System initiates notification to the LiveOps center where a nurse gets anotification on her dashboard. The nurse reviews the informationpresented by System, for example, pattern change seen, and responsesfrom Sam, Mrs. Jones and Mr. Pablo. The Nurse calls Mr. Jones to talk tohim and to determine how he is feeling. The Nurse determines Mr. Jonesis feeling short of breath and has trouble talking. The Nurse then callsthe MD and discusses Mr. Jones' situation, and they decide a medicationdose change is needed. The Nurse communicates the change in medicationregimen to Mrs. Jones and Mr. Jones. As a result, Mr. Jones alters hismedication.

The System continues to monitor his activity and patterns and seesimprovements gradually. The System periodically pushes notifications toMrs. Jones, Sam and Mr. Pablo to ask observational and interrogatoryquestions of Mr. Jones. System tracks that responses are trendingpositive. Over a period of a few days, Mr. Jones regains his normalpattern of activity.

The above scenario demonstrates the use of the system in a simple casewhere a slow functional decline is detected over a period of a few days.The use of spouse, family members and friends to conduct observationalfunctions as well as interrogatory functions effectively removed theneed for a nurse home visit in this case.

The use of the system as a sentinel effectively provided an earlywarning system that efficiently utilized higher levels of resources onlywhen needed (Nurse/MD) to ultimately effect a medication change thatmade Mr. Jones feel better and prevented a continued decline in state ofhealth that could have resulted in an ER visit or a hospital admission.

Without this system in place, it is conceivable that on Day 20 or Day 21when decline is much greater, the Jones would have called their MD foradvice, who then may simply schedule a nurse visit on Day 22 or perhapsan office appointment on Day 22 or simply, with an abundance of caution,direct Mr. Jones to the nearest ER. Alternately, by Day 22, by the timethe nurse visits or the office visit is due. Mr. Jones health issignificantly worse and he may end up going to ER in an ambulanceanyway.

Since re-hospitalization was prevented, the hospital, which dischargedMr. Jones less than 30 days ago, does not have the financial burden ofcaring for Mr. Jones for free due to re-admission for the same diagnosiswithin 30 days after discharge. In addition, the ACO that the Hospitalis part of now can show statistics that they have improved patientoutcomes even when the patient is outside their care setting, byemploying this remote monitoring sentinel system and thus be eligiblefor performance bonus from Medicare. Further, because the ACO andHospital outcomes statistics are made public and ranked by Medicare,both entities stand to benefit by the better reputation for outcomes andquality and can attract more patients. In both cases the few hundreddollars the hospital or ACO spends on this sentinel system per month perpatient saves them many thousands of dollars in potential revenue loss,gains of several thousands in performance dollars due to better outcomesand potentially a better reputation, which virtuously delivers morebusiness.

The components of the system can take any suitable form, including anysuitable hardware, software or other computerized components includingbut not limited to servers, processors, databases, memory devices,mobile applications, etc., capable of adequately performing theirrespective intended functions, as may be known in the art. Further,while the embodiment(s) are illustrative of the structure, function andoperation of the exemplary method(s) and system(s), it should beunderstood that various modifications may be made thereto with departingfrom the teachings herein.

While the foregoing discussion presents the teachings in an exemplaryfashion with respect to the disclosed methods and systems for remotelydetermining levels of healthcare interventions, it will be apparent tothose skilled in the art that the present disclosure may apply to anytype of method and system for monitoring a patient for healthcarepurposes. Further, while the foregoing has described what are consideredto be the best mode and/or other examples, it is understood that variousmodifications may be made therein and that the subject matter disclosedherein may be implemented in various forms and examples, and that themethod(s) and system(s) may be applied in numerous applications, onlysome of which have been described herein.

What is claimed is:
 1. A distributed and reconfigurable healthcarecommunication system comprising: a plurality of beacons disposed inrespective specific areas of a larger area, and configured to transmit acorresponding plurality of transmissions, wherein for each beacon, acorresponding transmission among the plurality of transmissions includesan identifier of the respective beacon associated with a correspondingarea among the specific areas in which the respective beacon isdisposed; a wearable sensor configured to continually monitor a wearercomprising: receiver circuitry for receiving at least one transmissionamong the plurality of transmissions transmitted by the plurality ofbeacons, at least one sensing device configured to sense activity of thewearer of the wearable sensor, to form sensed activity datarepresentative of the activity of the wearer, a non-transitory memory,and a processor coupled to the non-transitory memory, the processorconfigured to: a) identify a location of the wearer among the specificareas during the activity based on the corresponding identifier in thereceived at least one transmission b) determine a current functionalactivity of the wearer based on the sensed activity data and theidentified location and c) transmit current state information includingthe current functional activity and the corresponding identifiedlocation; a local communication system for wirelessly receiving thecurrent state information from the wearable sensor; a remote server incommunication with the local communication system; and a database forstoring the current state information and actions to be taken inresponse to events, wherein at least one of the wearable sensor, thelocal communication system or the remote server is configured toreconfigure the healthcare communication system by selectivelyincorporating one or more additional devices into said healthcarecommunication system under particular conditions to provide additionalwearer data, by (a) storing timestamped state information in thedatabase establishing at least one baseline activity pattern of thewearer, (b) detecting an event based on deviation of the current stateinformation from the at least one baseline activity pattern, (c) for theevent, determining a statistical significance of the deviation of thecurrent state information relative to the at least one baseline activitypattern, (d) selecting a care level among a plurality of hierarchicalcare levels based on the statistical significance of the deviation and aprevious health-state of the wearer automatically determined by thehealthcare communication system, at least one of a lower statisticalsignificance or a lower health-state variation associated with a lowercare level, and at least one of a higher statistical significance or ahigher health-state variation associated with a higher care level, (e)identifying an action to be performed among the actions stored in thedatabase corresponding to the detected event and (f) causing the remoteserver to perform the identified action, wherein the identified actionincludes: identifying, based on the selected care level, a care leveldevice of a contact associated with the selected care level;transmitting, by the remote server, over a communication network, aparticipation notification to the care level device based on thedetected event, the selected care level and a health-state of thewearer, displaying, on the care level device, at least oneevent-specific participatory task for requested performance by thewearer of the wearable sensor, responsive to the participationnotification; activating, by the remote server, the wearable sensor,such that the wearable sensor receives sensor data associated withwearer performance of the at least one participatory task displayed onthe computing device, transmitting, by the wearable sensor to the remoteserver, the received sensor data associated with the wearer performanceof the at least one participatory task, and automatically updating, bythe remote server, the health-state of the wearer based on evaluation ofthe received sensor data associated with the wearer performance of theat least one participatory task, the current state information, thedetected event, and predetermined clinical guidelines, to determinewhether to perform a further action by the remote server, wherein thefurther action includes obtaining additional health-state information ofthe wearer via a care level device of a different care level among theplurality of care levels, based on the updated health-state.
 2. Thesystem of claim 1, wherein each identifier and the corresponding areaare stored in the database.
 3. The system of claim 1, wherein the sensedactivity data includes motion of the wearer, the motion being inferredfrom changing beacon identifiers received by the wearable sensor.
 4. Thesystem of claim 1, wherein the at least one sensing device includes atleast one of a gyro, an accelerometer, a magnetometer, an inclinometer,a thermometer, or a galvanic skin response sensor.
 5. The system ofclaim 4, wherein the sensed activity data includes a direction oftravel.
 6. The system of claim 1, wherein the at least one sensingdevice includes an inclinometer and the sensed activity data includes aposture of the wearer.
 7. The system of claim 1, wherein the baselineactivity pattern corresponds to functional activity.
 8. The system ofclaim 7, wherein the functional activity is at least one of walking,sitting, reclining, standing, and lying down.
 9. The system of claim 1,wherein the plurality of beacons are infrared beacons.
 10. The system ofclaim 1, further comprising means for receiving information from anexternal device, wherein the baseline activity pattern is establishedbased at least in part on the received information.
 11. The system ofclaim 1, wherein at least some of the actions comprise establishing acommunication session between the wearer and the remote server, theremote server being configured to (i) transmit at least oneevent-specific request to the wearer, (ii) receive sensor data generatedby the wearable sensor during performance of the request, and (iii)perform a further action based on the event and the received sensordata.
 12. The system of claim 1, wherein at least one of the actions andthe further action is a disease-specific activity for a disease of thewearer.
 13. The system of claim 1, wherein the database stores, for thewearer, a list of contacts and one of the plurality of care levelsassociated with each of the contacts, the remote server being configuredto deliver, following detection of the event, a notification to a firstcontact of the list of contacts associated with a first care level. 14.The system of claim 13, wherein the notification includes at least oneof an observational component or an interrogatory component, the remoteserver being further configured to process responses to the notificationfrom the first contact.
 15. The system of claim 13, wherein the remoteserver is further configured to interact with the first contact and,based on the interaction, to determine whether to notify a secondcontact of the list of contacts associated with a different care level.16. A healthcare communication method for reconfiguring a distributedhealthcare communication system, the method comprising the steps of:transmitting a plurality of transmissions from a plurality ofcorresponding beacons of the healthcare communication system disposed inrespective specific areas of a larger area, wherein for each beacon, acorresponding transmission among the plurality of transmissions includesan identifier of the respective beacon associated with a correspondingarea among the specific areas in which the respective beacon isdisposed; receiving, by a receiver circuit of a wearable sensor of thehealthcare communication system configured to continually monitor awearer, at least one transmission among the plurality of transmissionstransmitted by the plurality of beacons; sensing, by at least onesensing device of the wearable sensor, activity of the wearer of thewearable sensor, to form sensed activity data representative of theactivity of the wearer; identifying, by a processor of the wearabledevice, a location of the wearer among the specific areas during theactivity based on the corresponding identifier in the received at leastone transmission; determining, by the processor of the wearable device,a current functional activity of the wearer based on the sensed activitydata and the identified location; transmitting, by the processor of thewearable device, current state information including the currentfunctional activity and the corresponding identified location;wirelessly receiving, by a local communication system of the healthcarecommunication system, the current state information from the wearablesensor; electronically storing, in a database of the healthcarecommunication system, the current state information and actions to betaken in response to events affecting the wearer; electronicallystoring, in the database, timestamped state information establishing atleast one baseline activity pattern of the wearer; reconfiguring, by atleast one of the wearable sensor, the local communication system or aremote server of the healthcare communication system, the healthcarecommunication system by selectively incorporating one or more additionaldevices into said healthcare communication system under particularconditions to provide additional wearer data, by: detecting, by at leastone of the wearable sensor, the local communication system or the remoteserver, an event based on deviation of the received current stateinformation from the at least one baseline activity pattern;determining, for the event, by at least one of the wearable sensor, thelocal communication system or the remote server, a statisticalsignificance of the deviation of the current state information relativeto the at least one baseline activity pattern; selecting by at least oneof the wearable sensor, the local communication system or the remoteserver, a care level among a plurality of hierarchical care levels basedon the statistical significance of the deviation and a previoushealth-state of the wearer automatically determined by the healthcarecommunication system, at least one of a lower statistical significanceor a lower health-state variation associated with a lower care level,and at least one of a higher statistical significance or a higherhealth-state variation associated with a higher care level, identifying,by at least one of the wearable sensor, the local communication systemor the remote server, an action to be performed among the actions storedin the database corresponding to the detected event; and causingperformance, by the remote server, of the identified action, wherein theidentified action includes: identifying, based on the selected carelevel, a care level device of a contact associated with the selectedcare level, transmitting, by the remote server, over a communicationnetwork, a participation notification to the care level device based onthe detected event, the selected care level and a health-state of thewearer, displaying, on the care level device, at least oneevent-specific participatory task for requested performance by thewearer of the wearable sensor, responsive to the participationnotification; activating, by the remote server, the wearable sensor,such that the wearable sensor receives sensor data associated withwearer performance of the at least one participatory task displayed onthe computing device, transmitting, by the wearable sensor to the remoteserver, the received sensor data associated with the wearer performanceof the at least one participatory task, and automatically updating, bythe remote server, the health-state of the wearer based on evaluation ofthe received sensor data associated with the wearer performance of theat least one participatory task, the current state information, thedetected event, and predetermined clinical guidelines, to determinewhether to perform a further action by the remote server, wherein thefurther action includes obtaining additional health-state information ofthe wearer via a care level device of a different care level among theplurality of care levels, based on the updated health-state.
 17. Themethod of claim 16, wherein the sensed activity data includes motion ofthe wearer, the motion being inferred from changing beacon identifiersreceived by the wearable sensor.
 18. The method of claim 16, wherein thestored at least one baseline activity pattern corresponds to functionalactivity.
 19. The method of claim 18, wherein the functional activity isat least one of walking, sitting, reclining, standing, and lying down.20. The method of claim 16, further comprising the steps of: storing inthe database, for the user, a list of contacts and one of the pluralityof care levels associated with each of the contacts; detecting theevent; and following the detection of the event, communicating anotification to a first contact of the list of contacts associated witha first care level.